DelveInsight’s “Idiopathic Inflammatory Myositis Market Insight, Epidemiology and Market Forecast – 2034” report delivers comprehensive insights into idiopathic inflammatory myositis, including historical and forecasted epidemiology, current treatment paradigms, and emerging therapies across the United States, EU4, the UK, and Japan. The idiopathic inflammatory myositis market size in the 7MM, valued at approximately USD 450 million in 2023, is projected to grow substantially at an impressive CAGR of 21.1% during the forecast period (2024-2034).
Furthermore, the US accounts for approximately USD 270 million of the total market share in 7MM in 2023, followed by EU4 and the UK with approximately USD 160 million. This remarkable growth is primarily attributed to the expanding patient pool, enhanced diagnostic modalities, and the introduction of premium-priced targeted therapies that address specific molecular alterations in idiopathic inflammatory myositis subtypes.
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According to DelveInsight’s epidemiological analysis, the total number of diagnosed prevalent cases of idiopathic inflammatory myositis in the 7MM was approximately 200K cases in 2023. Of these, the United States accounted for 48% of the cases, EU4 and the UK accounted for nearly 38%, and Japan represented 14% of the cases. Among the type-specific diagnosed prevalent cases in the US in 2023, approximately 31K were polymyositis, 38K were dermatomyositis, and 23K were inclusion body myositis. These figures are expected to increase throughout the forecast period, which will further drive market expansion.
The report further segmented idiopathic inflammatory myositis cases into total diagnosed prevalent cases, type-specific cases, gender-specific cases, and age-specific idiopathic inflammatory myositis cases.
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The current therapeutic landscape in idiopathic inflammatory myositis primarily includes corticosteroids as first-line therapy, often in combination with immunosuppressants like methotrexate, mycophenolate, or azathioprine for patients with inadequate response. In cases of severe or refractory disease, intravenous immunoglobulin and biologics such as rituximab, abatacept, and TNF inhibitors are considered. Among marketed drugs, OCTAGAM 10%, an intravenous immunoglobulin manufactured by Octapharma and distributed by Pfizer (NYSE: PFE), received FDA approval in July 2021 specifically for adult dermatomyositis, while VENOGLOBULIN-IH 5%, developed by Mitsubishi Tanabe Pharma, was approved in Japan in 2010 for treating muscle weakness in patients with polymyositis or dermatomyositis who show insufficient response to steroids.
DelveInsight’s analysis indicates that among the therapies currently in use, immunoglobulins held the largest market share, generating approximately USD 270 million in revenue in 2023 across the 7MM.
The idiopathic inflammatory myositis pipeline is robust, with several promising candidates in various stages of development. Dazukibart (PF-06823859), a potent humanized IgG1K monoclonal antibody developed by Pfizer (NYSE: PFE), selectively blocks interferon beta 1 and is currently in Phase III clinical trials for dermatomyositis and polymyositis. Efgartigimod, developed by Argenx (EBR: ARGX), targets the neonatal Fc receptor and is being evaluated in the ongoing ALKIVIA trial for three subsets of myositis. SAPHNELO (anifrolumab), a fully human monoclonal antibody by AstraZeneca (LON: AZN) that inhibits Type I interferons, has received orphan drug designation from the FDA in December 2022 and is in Phase III development for dermatomyositis.
As of March 2025, AstraZeneca is sponsoring a multicenter, randomized, placebo-controlled, double-blind Phase III study (NCT06455449) to evaluate the efficacy and safety of weekly subcutaneous anifrolumab as an add-on to standard of care in adults with idiopathic inflammatory myositis. Participants receive either anifrolumab or a placebo for 52 weeks, followed by an open-label extension where all participants receive anifrolumab for an additional 52 weeks.
In January 2025, RESTEM receives FDA Fast Track Designation for Restem-L, its lead umbilical cord lining stem cell (ULSC) therapy, for the treatment of Idiopathic Inflammatory Myopathy. This follows a recent Orphan Drug Designation for the same therapy in December 2024.
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According to DelveInsight’s experts, assessing disease activity in inflammatory myositis remains challenging due to the absence of validated biomarkers or objective measures. There is a significant need for reliable biomarkers, advanced imaging, and functional assessment tools to improve treatment decision-making and provide more accurate monitoring of treatment efficacy. The different subtypes of idiopathic inflammatory myositis, including polymyositis, dermatomyositis, and inclusion body myositis, exhibit distinct pathological mechanisms, highlighting the necessity for targeted therapeutic approaches.
A significant future opportunity in idiopathic inflammatory myositis lies in developing targeted therapies that address current unmet needs: limited efficacy of broad immunosuppressants and significant side effects from long-term steroid use. Given the diverse subtypes, biologic therapies tailored to subtype-specific immune pathways, such as JAK inhibitors and B-cell depleting agents, offer promise for more effective and safer treatment options. Additionally, biomarker-driven treatments could personalize therapy, enhancing outcomes by matching patients with drugs targeting specific disease mechanisms.
Table of Contents
1. Key Insights
2. Report Introduction
3. Market Overview at a Glance
4. Epidemiology and Market Forecast Methodology
5. Executive Summary
6. Key Events
7. Idiopathic Inflammatory Myositis Background and Overview
8. Idiopathic Inflammatory Myositis Patient Journey
9. Idiopathic Inflammatory Myositis Epidemiology and Patient Population
10. Idiopathic Inflammatory Myositis Marketed Drugs
11. Idiopathic Inflammatory Myositis Emerging Drugs
12. Idiopathic Inflammatory Myositis: Market Analysis
13. Key Opinion Leaders’ Views
14. SWOT Analysis
15. Idiopathic Inflammatory Myositis Unmet Needs
16. Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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